The present invention relates generally to dental appliances and more particularly to preformed, contoured dental oral barrier drape devices for isolating particular portions of a patient's mouth and teeth and to various corresponding retaining devices for maintaining the placement of such barrier drape devices.
When performing dental procedures such as crown and cavity preparations, and restorations, bonding and the like, it is well known in the art to utilize cotton rolls to isolate particular areas of a patient's mouth or oral cavity. The cotton rolls are used either loosely placed, or held in position by various clamping devices. As such, cotton rolls do not effectively preclude the accumulation of saliva over prolonged periods of operating time, nor do they isolate the operating area from moisture and bacterial contamination from the patient's breath. Further, cotton rolls do not guard or shield the throat and vulnerable respiratory tree and alimentary tract from foreign objects or debris.
To control and hold back, "dam", the saliva while effectively isolating a desired tooth, or group of teeth, it is well known in dental clinical practice to employ a thin, flat sheet of rubber material, a dam, to isolate the site to be operated upon from the remainder of a patient's mouth. In practice, the rubber dam is perforated by the practitioner in the pattern required to expose the operating site and the tooth (teeth) to be operated on. The perforated rubber dam is inserted into the patient's mouth and the perforated portions are stretched and forced down over the crown(s) of the tooth (teeth). The peripheral edges of the rubber dam are secured to an external frame to control the excess rubber dam material. Clamps or ligatures are attached to the neckline(s) of the tooth (teeth) over and superior to the surface of the rubber dam thereby preventing the rubber dam from slipping up over the crown(s) and off of the tooth (teeth).
Typically, the frame is external to the patient's mouth and lays against the patient's chin and/or cheeks. The rubber dam serves to isolate the teeth and the operating site from the moisture and bacterial contamination from the patient's breath. It further serves to prevent ingestion and/or aspiration by the patient of debris and foreign objects. Such prior art dental barrier devices are exemplified by the following U.S. patents.
U.S. Pat. No. 174,942 issued Mar. 21, 1876 to Parmly Brown discloses the use of a dental rubber dam having premolded concave depressions of oval or other convenient shape to suit the locations of the different teeth. The molded concave shape of Brown provides a depression in the rubber dam material which fits in the floor of the mouth or palate to relieve some of the puckering and wrinkling encountered with flat rubber dam material. However, this device provides no guidelines for isolation of individual or groups of teeth and fails to seal off the remainder of the oral cavity and protect the patient's throat and airway from operating debris, dental instruments or inadvertently dislodged devices.
U.S. Pat. No. 741,890 issued Oct. 20, 1903 to Henry Craigie discloses a rubber dental dam having annular rings or thickened borders formed in the dam material surrounding each intended perforation for the isolation of each tooth. The purpose of these annular rings is to act as clamping means in order to affix the dam to the exposed teeth. The annular rings are cumbersome to fit, tend to ride up over the teeth and place too much dam material in the interproximal regions. The device prevents full preparation of the crown portion of the tooth as the annulus portion of the dam material obscures the neckline areas of the tooth and gum.
U.S. Pat. No. 1,579,608 issued Apr. 6, 1926 to Samuel S. Haudenshield discloses a rubber dental dam having indicia printed or embossed on flat rubber dam material depicting the occlusal incisal surfaces of a full dentition to serve as a guide for the practitioner to punch perforations to expose the teeth at the operating site. While the indicia aid in exposing the operating site, because the indicia do not provide for irregularities in arch form and tooth position, punching in the indicated positions may make placement and installation of the rubber dam difficult and affect the effectiveness of the seal.
U.S. Pat. No. 2,092,549 issued Sept. 7, 1937 to John M. Craigo discloses the use of a preformed cup-shaped partial rubber dam designed to be utilized with only a few teeth in either arch. This appliance serves to isolate only the several teeth at the operating site and fails to seal off the remainder of the oral cavity and does not protect the patient's throat and airway from the debris formed by the operating procedure, dental instruments or inadvertently dislodged devices such as clamps or wedges.
Flat sheet dental rubber dams are difficult to place due to the resilient nature of the materials utilized. A flat sheet does not easily adapt to the complexities and varieties of curvatures and contours of the human oral cavity, such as the alveolar ridges supporting the teeth, the vestibules of the cheeks and lips, the floor of the mouth and the palate. Further, the resilient nature of the rubber dam material exerts a tension in the material when stretched over a tooth or teeth to be exposed and requires the use of strong, spring steel clamps to retain the rubber dam in position over a tooth. In addition to the tendency of the rubber dam to slip off of a tooth, the use of an external peripheral frame creates additional tension in the dam material which also tends to lift the clamping device off of the tooth thereby releasing the dam.
To retain prior art flat sheet rubber dams in place, a large variety of metal clamps having different forms and designs are available. Generally such metal clamps are formed of spring steel and have jaws with sharp edges and points which bite into the tooth at the tooth neckline above or superior to the surface of the dam material and retain the rubber material down below the neckline of the tooth. Such clamps are difficult to position requiring special instruments such as forceps, to hold and place them in a patient's mouth. Further, such clamps are often painful to the patient due to sensitive root surfaces. The clamps can incise the gingival tissues and chip or cut the surface of the root thus damaging the tooth. A likelihood exists that the clamps may become detached and inadvertently be ejected from the mouth or into the throat of the patients where they have been known to lodge in the trachea and lungs or the alimentary canal and stomach. To insure that such mishaps do not occur, it is necessary to attach a length of cord to each clamp to prevent loss or swallowing of a clamp should it inadvertently become loose in the patient's mouth.
Prior art dental rubber dam devices are difficult and time consuming for the practitioner to install and relatively uncomfortable for the patient. Further, the need for extremely high clamping forces to maintain the tensioned rubber dam in position can require the use of clamps which can damage the teeth and pose a potential life-threatening hazard to the patient. For these reasons many practitioners do not use the presently available rubber dam devices and risk the patient inadvertently aspirating or ingesting dental debris and instruments and unnecessary exposure to themselves of infection transmittal from the patient, such as various forms of hepatitis, respiratory infections and acquired immune deficiency syndrome (AIDS), as well as potential liability if the patient accidentally ingests foreign material such as the operating debris or a dental device.